BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 10001201 · Received April 27, 2020

    Report

    Report Number
    3013756811-2020-40470
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    April 2, 2020
    Report Date
    April 27, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCHSCREEN WAS CRACKED AND UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE (BG) WAS 243-244 MG/DL. REPORTEDLY, CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464772 T:SLIM X2 INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1